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NCT01488890 · ClinicalTrials.gov registry record · Phase 2
Immune Response to Different Schedules of a Tetravalent Dengue Vaccine Given With or Without Yellow Fever Vaccine
A Phase 2 study of Dengue and Yellow Fever, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 390
- Enrollment target
- 7
- Study locations
NCT01488890: Completed Phase 2 study of Dengue and Yellow Fever, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT01488890 is a Phase 2 study of Dengue and Yellow Fever that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 390 participants, below the 3,938-participant average among 9 other Dengue trials with a reported enrollment target (90% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01488890, a Phase 2 study of Dengue and Yellow Fever, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 390 participants
- Enrollment target
- 7
- Study locations
Study Summary
The aim of this study was to evaluate the administration of CYD dengue vaccine serotypes (1, 2, 3 and 4) following a compressed schedule in 3 different populations. Primary Objectives: * To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after CYD dengue vaccine Dose 3 in Group 1 (Month \[M\] 13) and Group 2 (M07), irrespective of whether or not Yellow Fever (YF) vaccine has been previously administered. * To describe the persistence of the humoral immune response to each of the 4 parental dengue virus serotypes 6 months after CYD dengue vaccine Dose 3 in Group 1 (M18) and Group 2 (M12), irrespective of whether or not YF vaccine has been previously administered. Secondary Objective: * To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after CYD dengue vaccine Dose 1 and Dose 2 in Groups 1 and 2, irrespective of whether or not YF vaccine has been previously administered. * To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after CYD dengue Dose 1 in the combined YF-participants in Group 1 (N=60) and Group 2 (N=60), and in Group 3 (N=120). * To describe by FV status at baseline the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after each injection of CYD dengue vaccine in Groups 1, 2, and 3. * To describe the safety profile after each injection of CYD dengue vaccine and/or YF vaccine.
Primary Outcome
GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue plaque reduction neutralization test (PRNT).
Conditions Studied
Interventions
- BIOLOGICAL Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus
- BIOLOGICAL Yellow Fever
Study Locations (7)
Alabama
- - Alabaster
California
- - Sacramento
Florida
- - Jacksonville
Maryland
- - Silver Spring
Missouri
- - Springfield
Nevada
- - Las Vegas
Utah
- - West Jordan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 390 participants |
| Start Date | 2011-12-06 |
| Est. Completion | 2013-09-27 |
| Phase | Phase 2 |
What the finished NCT01488890 record still lists
NCT01488890 is an interventional study that assigns participants to a tested intervention. The registered 390 participants enrollment target is mid-sized for trials with a published cap, below the 3,938-participant average among 9 other Dengue trials with a reported enrollment target (90% lower).
The record links to 4 conditions, with Dengue appearing as the primary indexed condition, and to 2 interventions - of which Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus is the first listed.
NCT01488890 lists 7 locations in 7 states (Alabama, California, Florida).
Frequently Asked Questions
What is clinical trial NCT01488890 about?
NCT01488890 is a clinical study titled "Immune Response to Different Schedules of a Tetravalent Dengue Vaccine Given With or Without Yellow Fever Vaccine". The aim of this study was to evaluate the administration of CYD dengue vaccine serotypes (1, 2, 3 and 4) following a compressed schedule in 3 different populations. Primary Objectives: * To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 day...
What is the current status of trial NCT01488890?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 390 participants. The study started on 2011-12-06. Estimated completion is 2013-09-27.
What conditions does trial NCT01488890 study?
This clinical trial studies the following conditions: Dengue, Yellow Fever, Dengue Hemorrhagic Fever, Dengue Fever.
What interventions are being tested in trial NCT01488890?
The interventions under investigation include: Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus (BIOLOGICAL), Yellow Fever (BIOLOGICAL).
Who is sponsoring clinical trial NCT01488890?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01488890 being conducted?
This trial has 7 study locations across Alabama, California, Florida, Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dengue
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01488890's enrollment target sits among peer trials
390 2nd of 9 the highest of 9 other Dengue trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dengue trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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